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Cardiac Science Corporation

USA · Bothell

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Hong Kong, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

21510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

30active device licences

Class II 21Class III 7Class IV 2

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class III 2

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 21 510(k), 0 PMA, 44 excluded

Brazil0 confirmed, 7 excluded

Canada30 confirmed, 8 excluded

Manufacturer names merged into this page: CARDIAC SCIENCE CORPORATION

Registration details (sample)

Market	Identifier	Name	Class / date
US	K143714	Powerheart G5 AED	2015-05-04
US	K122758	POWERHEART G5 AED	2014-02-12
US	K113176	MYSENSE HEART	2011-12-21
CA	1422	QUINTON SYNERGY CARDIOLOGY INFORMATION SYSTEM (CIS)	Class II
CA	1850	EK10 ELECTROCARDIOGRAPH	Class II
CA	5375	QUINTON 412 AUTOMATIC STRESS TEST BLOOD PRESSURE MONITOR	Class II

Cardiac Science Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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